Actively Recruiting
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Led by Nyrada Pty Ltd · Updated on 2026-05-07
300
Participants Needed
6
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study. Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days. Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30. Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.
CONDITIONS
Official Title
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent.
- Male patients aged 40 to 75 years.
- Female patients aged 55 to 75 years or females aged 40 to 55 years who cannot become pregnant.
- First-time STEMI presentation, planned primary PCI within 6 hours of symptom onset, with door to balloon time less than 2 hours.
- ST elevation at the J-point in two contiguous leads along with symptoms consistent with acute myocardial infarction.
- Hemodynamically stable: systolic blood pressure ≥ 90 mmHg and heart rate 50-120 bpm.
- Killip Class I or II.
- Oxygen saturation ≥ 92% on room air or low-flow oxygen.
- No ongoing ventricular tachycardia or fibrillation at enrollment.
- Male participants with female partners of child-bearing potential must be willing and able to use highly effective contraception for at least 7 days after investigational product administration.
You will not qualify if you...
- History or ECG evidence of prior myocardial infarction or cardiomyopathy.
- Previous major cardiac surgery, including coronary artery bypass graft surgery.
- Known contraindications to cardiac magnetic resonance imaging (e.g., pacemakers, cochlear implants, aneurysm clips, claustrophobia, allergy to contrast).
- Clinically significant renal impairment requiring dialysis or estimated glomerular filtration rate less than 30 mL/min.
- Body weight less than 50 kg or greater than 120 kg at screening.
- Current enrollment in another investigational drug or device trial or within 30 days or 5 half-lives since completion of another investigational treatment.
- Life expectancy under 1 year due to non-cardiac conditions as judged by the investigator.
- Any condition or clinical abnormality that would prevent safe study completion.
- Known hypersensitivity to the investigational drug, its components, or soy or egg products and derivatives.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Not Yet Recruiting
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
4
Northern Health
Epping, Victoria, Australia, 3076
Not Yet Recruiting
5
Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Not Yet Recruiting
6
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
Research Team
A
Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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